FDA approves new vaccine

In December 2014, the Food and Drug Administration approved a new vaccine against genital HPV (Human Papillomavirus).  Great news for public health!

Prior to this development, there were two HPV vaccines available.  The original Gardasil vaccine was approved in 2006 to guard against two strains (16 and 18) of HPV that are responsible for approximately 75% of cervical cancer cases, 70% of vaginal cancer cases, and 50% of vulvar cancer cases.  It also offers prevention for two strains (6 and 11) that are responsible for 90% of genital warts cases.  It is available for both females and males ages 9 to 26.  The second HPV vaccine, Cervarix, was approved in 2009 for females only, ages 9 to 26, to provide protection against strains 16 and 18. 

The new Gardasil 9 vaccine, however, will protect against an additional five strains of HPV (31, 33, 45, 52, and 58).  According to Merck, the manufacturer of Gardasil 9, this will allow for protection against approximately 90% of cervical cancers caused by HPV, as well as 85-95% protection against HPV-related vulvar, vaginal, and anal cancers.  Gardasil 9 has been approved for use in females ages 9 to 26, and for males ages 9 to 15.  The original Gardasil was the first vaccine ever to prevent against cancer, and along with Cervarix and now Gardasil 9, these are still the only immunizations available for cancer prevention.

So, are you thinking that you should start recommending Gardasil to your patients ASAP?  You may need to hold tight for a little bit longer.  It could still be some time before a parent or young person can find Gardasil 9 at their primary provider or local health department.  While approved, the new vaccine will have many hoops to jump through before it is mass marketed, including manufacturing of the vaccine on a large scale and getting approval from insurance companies for coverage.  Additionally, the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) still needs to issue public health advice for how Gardasil 9 should be used and recommended for patients, especially in relation to the current HPV vaccines available.  ACIP is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States.  It is hoped that decisions from this group about Gardasil 9 will take place early in 2015.

Genital HPV is the most common sexually transmitted infection in the United States.  So common, in fact, that, according to the CDC, nearly all sexually active adults will get at least one type of HPV at some point in their lives.  While most of the strains of HPV go away on their own and do not cause any health problems, as mentioned, several can lead to certain cancers or genital warts.  The CDC’s number one recommendation for protecting against HPV is to become vaccinated.  To provide the most protection and receive the best response from the vaccine, they recommend that all girls and boys should receive their 3-shot series of HPV vaccine (currently the original Gardasil or Cervarix as appropriate) at age 11 or 12, a common age for a well-child physical during which other important immunizations are administered.  If this window is missed, the CDC still recommends HPV vaccination for teen and young women up to age 26, and teen and young men up to age 21.

However, these recommendations are not being adequately adhered to by most families or young people.  For example, from the 2013 National Immunization Survey-Teen, it was found that for girls ages 13-17, less than 60% had received even one dose of the HPV vaccine.  This is despite the fact that more than 90% of 13 year old girls would have received at least one dose if they had been given the HPV vaccine at the same time they received other recommended vaccines.

So please recommend the HPV vaccine to your patients and explain why it is so important!  If a parent is reluctant, find out why.  Financial concerns, a lack of information about the benefits, or a fear that a vaccine for a sexually transmitted infection will lead to increased sexual activity?  Provide appropriate counseling that addresses the worries of your patient or the patient’s parents.  (For example, a recent large-scale study from the Canadian Medical Association Journal found no relationship between young girls receiving the HPV vaccine and an increase in risky sexual activity.)  The HVP vaccination is a huge victory for women’s health specifically, and public health in general, but only if both females and males are vaccinated.

References:
http://www.cdc.gov/std/HPV/STDFact-HPV.htm

http://www.cdc.gov/hpv/vaccine.html

http://www.gardasil.com/

http://www.immunize.org/askexperts/experts_hpv.asp

http://www.cervarix.ca/

http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-hpv-vaccine-gardasil9-prevent-cancers-an

http://www.cdc.gov/vaccines/who/teens/vaccination-coverage.html

http://www.cmaj.ca/content/early/2014/12/08/cmaj.140900.full.pdf+html?sid=a795523d-97a9-4012-82af-647c35cfdb81

 

 

 

 

 

Revised: January 7, 2015

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